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U.S. Department of Health and Human Services

Product Classification

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Device ventilator, non-continuous (respirator)
Regulation Description Noncontinuous ventilator (IPPB).
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBZD
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5905
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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